Company: Medtronic Inc. Cardiac Rhythm Management
Date of Enforcement Report:11/14/2007
Class:lll

PRODUCT
Medtronic Paceart System, 2006 Edition, The Paceart System can act as a Practice Management software application and is intended for use by facilities that provide services such as event monitoring, trans-telephonic pacemaker evaluation, and in-office evaluation of implanted cardiac devices; Recall # Recall Number : Z-0081-2008

REASON
An issue with the Paceart System – 2006 First Edition (Get Connected Edition) exists. Under certain circumstances, Paceart System Generic ICD reports may not accurately reflect patient VT/VF, SVT/NST and Mode Switch/AT/AF episode detection data. When episode detection data is imported into the Paceart System from certain sources, the Paceart System Generic ICD reports display a zero, suggesting no episodes have occurred, instead of indicating that no data is available.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Inc. Cardiac Rhythm Management, Minneapolis, MN, by letter on August 27, 2007.
Manufacturer: Medtronic Paceart, Arden Hills, MN. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
721 units

DISTRIBUTION
Nationwide